Recently, the PUMCH Clinical Pharmacology Research Center opened to the whole hospital its clinic, the pharmacy and the day ward, in a bid to improve PUMCH’s clinical research platform. Following the principle of “integrated arrangement, international standards and professional services”, the Center takes the key technology of clinical research and evaluation as the core, and provides up-to-standard, smooth, efficient, standardized and safe services for researchers, sponsors and subjects throughout the process of clinical research to facilitate the innovations in bio-medicine.

Clinical research is a major approach to evaluating and verifying whether a biomedical product is safe and effective, as well as a core step throughout the innovation chain that is time-consuming and requires a large amount of input. The “Opinions on Promoting the High-Quality Development of Public Hospitals” issued by the General Office of the State Council clearly states the need to strengthen clinical research, tackle hard-nut problems in science and technology, and promote commercialization of scientific and technological findings. Vigorously carrying out clinical research is not only the core need of scientific and technological innovation at hospitals, but also a path that hospitals must take for high-quality development. The PUMCH Clinical Pharmacology Research Center and the leading companies in pharmaceutical innovation continue to deepen cooperation, to establish an innovation chain that covers “basic research, clinical application, translational medicine, and commercialization of research findings”, and create a “PUMCH model” in clinical research.

Clinic for Clinical Trial Opened as an Area Dedicated to Subjects Screening and Follow-up

The Clinic for Clinical Trial, located at the south of the 1st floor of the Translational Medicine Complex, is a specialized area for investigators to screen and follow up with subjects. Research nurses are available at all times to provide “one-stop” examinations for subjects, reducing their waiting time and travel to different areas of the hospital. At the same time, clinical laboratory scientists provide personalized sample processing services.

Investigators can book consulting rooms on their own based on the clinical research protocol, and they can screen and follow up with subjects even if it is not their working day. In addition, investigators can issue medical instructions for venous blood collection in clinical trials through HIS, which further standardizes the collection of specimens and enables traceability by electronic means.

Pharmacy for Clinical Trial Put into Use to Ensure Safe Drug Use for Subjects

The pharmacy for clinical trial is located at the integrated examination section in the corridor connecting the 2nd floor of the Translational Medicine Complex and the Internal Medicine Building, equipped with room temperature storage cabinets and low temperature refrigerators. It is under temperature and humidity monitoring and an alarm will be triggered whenever there is a problem with the pharmacy. Moreover, it establishes Standard Operating Procedures (SOP) and quality management system for clinical trials, and adopts an electronic drug management system. Managed by a team of professional pharmacists from the Clinical Pharmacology Research Center, the pharmacy for clinical trial provides one-stop drug management services for receiving, warehousing, distributing and retrieving drugs.

Clinical pharmacists will develop a drug management plan based on the trial protocol and the characteristics of drugs. Each clinical research project has two qualified pharmacists in charge of receiving, storing, distributing, retrieving and returning drugs, and each procedure is checked by them respectively, to minimize the risk of protocol violation or deviation due to drug factors, improve the quality of clinical research, and ensure safe drug use for subjects.

Day Ward Put into Use, Open to All Phase II and III Clinical Research Projects in PUMCH

The day ward of the Clinical Pharmacology Research Center, located at the southwest of the 7th floor of the Translational Medicine Building, is a professional research ward established in line with the national new version of Good Clinical Practice (GCP). Under unified closed-off management, it has 48 standardized research beds, independent resuscitation room, data room, CRC office, CRA office, sample processing room and other functional zones.

The Clinical Pharmacology Research Center has a well-trained and dedicated research team, whose members have received systematic and comprehensive training on standardized clinical trials and have rich practical experience in clinical trials. They can provide the services of drug administration, blood collection, specimen processing, and pharmacokinetic and pharmacodynamic analysis throughout the process of clinical research projects.

The Clinical Pharmacology Research Center has established a standardized clinical trial management system and an independent clinical trial ethics committee. Geared towards clinical needs, it provides comprehensive technical support and whole-process information management for clinical trial projects. In addition, it strengthens the whole-process quality control of clinical trials, continuously optimizes processing and service procedures, and takes such new measures as establishing a paperless system for project approval, contracts and ethics review, to enhance the quality and efficiency of clinical research and ensure its smooth implementation.

PUMCH is committed to becoming a place where medical and pharmaceutical innovations originate, to bring more new drugs, new technologies and new treatment options to patients. The official opening of the clinic for clinical trial, the pharmacy for clinical trial and the day ward in the Clinical Pharmacology Research Center will optimize and upgrade the services throughout the whole process of clinical trials at PUMCH, marking a key step in the construction of the PUMCH clinical research platform.

Correspondents: Zhao Xue and Zhang Yang

Reporter: Li Yuanjing

Picture courtesy: Sun Liang

Translator: Liu Haiyan

Editor: Wang Hongyun and Wang Yao